Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues
Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 452,392 units distributed in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential power issues in a medical device used for monitoring blood glucose, which poses a risk of harm if the device fails, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diabetes Care, Inc. is recalling the Accu-Chek Guide Blood Glucose Monitoring System, Model Number 08313202001, due to potential power issues. The affected product is the ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX. The system is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control for people with diabetes.
The recall involves 452,392 units. Distribution was US Nationwide and in the following countries: AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA. The affected serial numbers are all below XXX11000001, where XXX is the first 3 digits of the serial number. The Device Identifier is 00365702702349.
Consumers should stop using the affected devices and contact Roche Diabetes Care for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper a
- Manufacturer
- Roche Diabetes Care, Inc.
- Hazard
- Affected units
- 452,392
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Roche Diabetes Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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